MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® ITRACONAZOLE

Catalog Number	525858
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of out of range low results for internal quality controls (qc) in association with etest® itraconazole (reference 525858).The customer reported that at 24 hours they had a mic value of 0.016 on multiple test strips.At 48 hours the customer reported test results of 0.032.The customer has tested the same lot of strips with multiple lots of organisms and media.The customer ordered another order of strips, and received the same lot.They tested the new kit of etest® strips and received similar results.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united states notified biomérieux of out of range low results for internal quality control (qc) strain candida albicans (atcc 90028) in association with etest® itraconazole (reference (b)(4)).An mic value of 0.032 g/ml was obtained for an expected mic value range of 0.064-0.25 g/ml.An internal biomérieux investigation was performed.Retained sample analysis: the conformity of the lot reported, 1005507630, and a reference lot 1005871860 used during the investigation, were confirmed with the atcc quality control strains tested for the release of this reference: atcc (b)(6) candida parapsilosis, atcc (b)(6) candida krusei, atcc (b)(6) candida albicans.Complaints trend analysis: no other complaint was registered on this lot.The trend analysis was reviewed and did not indicate any issues with this product.Conclusion: the results obtained with the atcc quality control strains tested during this investigation conformed with the product specifications.No other complaints were registered on this lot number and the trend analysis of the complaints does not show any problem on this reference.No further actions were deemed necessary.

• Brand Name: ETEST® ITRACONAZOLE
• Common Device Name: ETEST® ITRACONAZOLE
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383, ; FR
• MDR Report Key: 7620578
• Report Number: 3002769706-2018-00086
• Device Sequence Number: 11160410
• Product Code: NGZ
• UDI-Device Identifier: 03573026253318
• UDI-Public: 03573026253318
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2020
• Device Catalogue Number: 525858
• Device Lot Number: 1005507630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1